Original ResearchFull Report: Clinical—Alimentary TractNew Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding: A Systematic Review and Meta-analysis
Section snippets
Study Definitions
The exposure of interest was defined as the (approximated) indication-specific recommended daily dose of the nOAC either by the European Medicines Agency12 or the Food and Drug Administration13 for registered nOAC. When nOAC was not registered for the indication for which it was studied, the indication-specific daily dose was defined according to the pharmaceutical manufacturer.
Standard care was defined as either low-molecular-weight heparin, vitamin K antagonist, antiplatelet therapy, or no
Studies
Our initial search identified 375 records (Figure 1A). A total of 42 studies were eligible for inclusion. The agreement between reviewers for trial inclusion was excellent (κ, 0.94). The clinical indication comprised AF in 8 studies,9, 10, 25, 26, 27, 28, 29, 30 OS in 21 studies,31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51 medically ill patients in 2 studies,52, 53 DVT/PE in 6 studies (reporting on 7 trials),54, 55, 56, 57, 58, 59 and ACS in 5 studies (
Discussion
This systematic review and meta-analysis on 43 trials shows that the nOACs are associated with a modest, but significantly higher, risk of GIB compared with current standard care. This risk is the highest in patients treated for thrombosis (ACS and DVT/PE). In ACS, nOACs were administered on top of other antithrombotic medication, increasing the well-known cumulative risk of GIB.5 The risk of GIB in patients treated for DVT/PE or receiving thromboprophylaxis for AF is higher than in patients
Supplemental Material
Note: To access the supplementary material accompanying this article, visit the online version of Gastroenterology at www.gastrojournal.org, and at http://dx.doi.org/10.1053/j.gastro.2013.02.041
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Conflicts of interest The authors disclose no conflicts.